Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's Patients

Crohn's Disease Clinical Trial

Official title:

Oral Calcium Supplementation, a Strategy to Reduce Kidney Stones in Crohn's Patients Living With a Small Bowel Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01735461
• Other study ID #: H11-02525
• Status: Recruiting
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: Olga Arsovska
• Phone: 6048754111
• Email: olga.arsovska[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hospitalization for kidney stones in the Inflammatory Bowel Disease (IBD) population is common, particularly among Crohn's patients who had a small bowel resection. This patient population experiences a lifetime occurrence of kidney stone formation as high as 25% accompanied with a high rate of recurrence (the typical rate of stone formation is ~10% in the non IBD population). Giving oral calcium is used to bind oxalate in the intestine in an attempt to reduce the amount of oxalate that is absorbed into the body and to reduce urinary oxalate levels. However, there are no defined guidelines for the optimum dosing of calcium. This study's primary objective is to scientifically define an appropriate range of calcium supplementation that reduce the level of oxalate found in the urine of patients living with inflammatory bowel disease.

Description:

The primary objective of this study is to establish optimal oral calcium supplementation in Crohn's patients who have had an ileal bowel resection. This population is at high risk for calcium oxalate kidney stones, a direct consequence of extensive gut malabsorption and enteric hyperoxaluria. The benefit of providing oral calcium in this patient population (as a means to reduce intestinal oxalate absorption) is known, however, there are no appropriate targets for calcium dosing, which is presently performed empirically or not at all. Our goal is to establish simple, safe and practical guidelines for calcium supplementation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. a pathologically confirmed diagnosis of Crohn's disease

2. prior ileal resection with an intact colon (surgery>6 months preceding involvement in study)

3. hyperoxaluria (defined as> 48 mg (>0.5 mmol) per 24 hour urine samples.

• Patients will not be excluded if they are known kidney stone formers.

Exclusion Criteria:

1. current pregnancy

2. patient's without baseline hyperoxaluria (defined as >48 mg or 0.5mmol per 24 hour urine samples)

3. patients in renal failure assessed by a GFR < 60

4. inability to provide informed consent

5. active cancer

6. hyperparathyroidism

7. hyperphosphatemia

8. <19 years of age

Related Conditions & MeSH terms

• Calculi
• Crohn Disease
• Crohn's Disease
• Kidney Calculi
• Nephrolithiasis

Intervention

Dietary Supplement:
• Calcium Carbonate
There is a regimen for dietary supplement intake that will be provided to study participants.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	University of Texas Southwestern Medical Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate	Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate will be calculated from the 24-hour urine test.; The patient will take dietary calcium for 7 days and then we will evaluate their urine chemistry. Additionally, 24-hour urine collections are considered the standard for urinalysis in comparison to spot urine chemistry. The initial data, prior to calcium supplementation, will serve as the control, providing the patient's baseline risk for kidney stone formation.	7 days
Secondary	Optimal level of Ca supplementation for prevention of stones in Crohn's patients	Practical guidelines for physicians managing Crohn's patients will be developed based on the optimal Ca supplement dosages and determine the optimal level of calcium supplementation in each patient, based on urinary parameters from 24-hour urine.	7 days